Cleared Traditional

K973587 - EXMOOR TYMPANOCENTESIS KIT (TK/1) (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K973587 · Exmoor Plastics , Ltd. · Ear, Nose, Throat device
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Jan 1998
Decision
123d
Days
Class 1
Risk

K973587 is an FDA 510(k) clearance for the EXMOOR TYMPANOCENTESIS KIT (TK/1). Classified as Tube, Ear Suction (product code JZF), Class I - General Controls.

Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on January 23, 1998 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Exmoor Plastics , Ltd. devices

Submission Details

510(k) Number K973587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1997
Decision Date January 23, 1998
Days to Decision 123 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 89d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZF Tube, Ear Suction
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.